Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001205325
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
9/09/2026
Date registered
Help: Date registered
30/09/2026
Date last updated
Help: Date last updated
21/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
30/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1, open-label single dose study to assess the pharmacokinetics and relative bioavailability of subcutaneously administered Claseprubart (DNTH103) across different injection sites and delivery methods in Healthy Volunteers.
Scientific title
A Phase 1, open-label single dose study to assess the pharmacokinetics and relative bioavailability of subcutaneously administered Claseprubart (DNTH103) across different injection sites and delivery methods in Healthy Volunteers.
Additional trial identifiers [1] 318255 0
DNTH103-HV-102
Universal Trial Number (UTN)
Trial acronym
CLARITY
Related trial records
ACTRN12622001265763 Registered 23 Sep 2022 Previous sub study.
A Phase 1, Placebo-Controlled, Single/Multiple Ascending Dose Study of DNTH103 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Intravenous and Subcutaneous Administration in Healthy Volunteers.

Health condition
Health condition(s) studied:
Complement Mediated Diseases 343325 0
Condition category
Condition code
Inflammatory and Immune System 339429 339429 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Approximately 108 participants are planned to be enrolled into 3 anatomical site groups
(ie, abdomen, front of upper thigh, or outer arm) and, within the group, randomized to
receive a single dose of 300 mg claseprubart delivered subcutaneously using either the
Autoinjector (AI), Accessorised Pre-filled syringe (APFS), or Vial and Syringe (V/S) method.
1. Autoinjector: A single-use, spring-loaded device that automatically inserts the needle and delivers the study drug subcutaneously when activated against the skin.
2. Accessorized pre-filled syringe: A single-use pre-filled syringe fitted with accessories to facilitate subcutaneous administration of the study drug. The needle is manually inserted into the skin, and the study drug is delivered by depressing the syringe plunger.
3. Vial and syringe: The study drug is withdrawn from a vial into a syringe using a needle and subsequently administered subcutaneously by manual injection.
Approximately 12 participants will be assigned to each delivery method cohort within the anatomical site group.
Participants following a single subcutaneous injection of claseprubart on Day 1 will continue to be monitored through to Day 42 (End of Study).
Participants will receive all subcutaneous injections of study treatment directly from the Investigator or qualified designee in the clinic.
Adherence to intervention will be noted in the study treatment and compliance records.
Intervention code [1] 335147 0
Treatment: Drugs
Description of the comparator or control
No control group. This is an open label trial.
Participants will be recruited with the intention to dose at one injection site, e.g. abdomen. Participants will then be randomised to the injection device/delivery method e.g. abdomen + autoinjector vs abdomen + pre-filled syringe vs abdomen + vial and syringe.
Control group
Active

Outcomes
Primary outcome [1] 346644 0
Compare the pharmacokinetics and relative bioavailability of a single dose of claseprubart administered subcutaneously across different injection sites (abdomen, thigh, and upper arm) in healthy adult participants. Assessed as a composite outcome.
Timepoint [1] 346644 0
PK sampling at pre dose (-30 mins), 1 hr post dose, 6 hr post dose, 24hrs (Day 2) post dose, 48 hr (Day 3) post dose, 96hr (Day 5) post dose, 168hr (Day 8) post dose, 336hr (Day 15) post dose, 504hr (Day 22) post dose, 672 hr (Day 29) post dose, 840hr (Day 36) post dose, 1008 hr (Day42/End Of Study (EOS)) post dose
Primary outcome [2] 346951 0
Compare the pharmacokinetics and relative bioavailability of a single dose of claseprubart administered subcutaneously across different injection delivery methods (autoinjector [AI], accessorized prefilled syringe [APFS], and vial with syringe [V/S]) in healthy adult participants. Assessed as a composite outcome.
Timepoint [2] 346951 0
PK sampling at pre dose (-30 mins), 1 hr post dose, 6 hr post dose, 24hrs (Day 2) post dose, 48 hr (Day 3) post dose, 96hr (Day 5) post dose, 168hr (Day 8) post dose, 336hr (Day 15) post dose, 504hr (Day 22) post dose, 672 hr (Day 29) post dose, 840hr (Day 36) post dose, 1008 hr (Dday42/End Of Study (EOS)) post dose.
Secondary outcome [1] 466898 0
Assess the safety of a single dose of claseprubart administered subcutaneously across different injection sites (abdomen, thigh, and upper arm) in healthy adult participants.
Timepoint [1] 466898 0
Timepoint: Daily from Screening, Confinement (Day -1, Day 1 (Dosing) and Day 2), Day 3, Day 8, Day 15, Day 22, Day 29, Day 36 and Day 42 post-dose (EOS).
Secondary outcome [2] 466899 0
Assess the safety of a single dose of claseprubart administered subcutaneously across different injection delivery methods (AI, APFS, and V/S) in healthy adult participants.
Timepoint [2] 466899 0
Timepoint: Daily from Screening, Confinement (Day -1, Day 1 (Dosing) and Day 2), Day 3, Day 8, Day 15, Day 22, Day 29, Day 36 and Day 42 post-dose (EOS).
Secondary outcome [3] 468304 0
Assess the tolerability of a single dose of claseprubart administered subcutaneously across different injection sites (abdomen, thigh, and upper arm) in healthy adult participants.
Timepoint [3] 468304 0
Timepoint: Daily from Screening, Confinement (Day -1, Day 1 (Dosing) and Day 2), Day 3, Day 8, Day 15, Day 22, Day 29, Day 36 and Day 42 post-dose (EOS).
Secondary outcome [4] 468305 0
Assess the tolerability of a single dose of claseprubart administered subcutaneously across different injection delivery methods (AI, APFS, and V/S) in healthy adult participants.
Timepoint [4] 468305 0
Timepoint: Daily from Screening, Confinement (Day -1, Day 1 (Dosing) and Day 2), Day 3, Day 8, Day 15, Day 22, Day 29, Day 36 and Day 42 post-dose (EOS).
Secondary outcome [5] 468306 0
Assess the immunogenicity of a single dose of claseprubart administered subcutaneously across different injection sites (abdomen, thigh, and upper arm) in healthy adult participants
Timepoint [5] 468306 0
Blood sampling at: 6hrs predose on Day 1, Day 15 and Day 42 post-dose (EOS)
Secondary outcome [6] 468307 0
Assess the immunogenicity of a single dose of claseprubart administered subcutaneously across different injection delivery methods (AI, APFS, and V/S) in healthy adult participants
Timepoint [6] 468307 0
Blood sampling at: 6hrs predose on Day 1, Day 15 and Day 42 post-dose (EOS)

Eligibility
Key inclusion criteria
Must have given written informed consent before any study-related activities are carried out and must be able to understand the nature and purpose of the trial, including possible risks and adverse effects.

2. Adult males and females, 18 to 75 years of age (inclusive) at Screening.

3. Body mass index (BMI) less than and including 34 kg/m2 with a body weight (to 1 decimal place) greater than and including 50 kg and less than and including 90 kg at Screening and Day -1 check-in.

4. Be non-smokers (including tobacco, e-cigarettes and marijuana) for at least 3 months prior to first study drug administration.

5. Medically healthy in the opinion of the Investigator at the Screening visit and on Day -1 check-in, based on medical history, physical examination, and clinical laboratory tests.

6. Female volunteers must:
a. Be of nonchildbearing potential, i.e., permanently surgically sterilized (hysterectomy,
bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before Screening) or
postmenopausal (where postmenopausal is defined as no menses for 12 months without an
alternative medical cause and a follicle-stimulating hormone (FSH) level greater than and including 40 IU/L at
Screening), or

b. If of childbearing potential, must agree not to donate ova, not to attempt to become
pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception from signing the study informed consent form
(ICF) until discharged from the study.

7. Male volunteers must:
a. Agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception from signing the study ICF until discharged from the study, or

b. Be surgically sterile by bilateral orchidectomy or vasectomy at least 90 days prior to
Screening.

8. Have suitable venous access for blood sampling.

9. Previously immunized against encapsulated bacterial pathogens as per country-specific
guidelines (Neisseria meningitidis, Haemophilus influenzae, and Streptococcus pneumoniae within past 5 years) or willing and able to be vaccinated during the Screening Period and 14 days prior to claseprubart administration on Day 1.

10. Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within 3 months prior to Screening determined by the Investigator to be clinically significant.

2. History of autoimmune disease at Screening.

3. History of active malignancy within 5 years prior to Screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone.

4. Liver test results during Screening or at check-in day (Day -1) that are elevated more than 1.5-fold above the upper limit of normal (ULN) for gamma-glutamyl transferase (GGT), bilirubin (total), aspartate aminotransferase (AST) or alanine aminotransferase (ALT), unless a diagnosis of Gilbert syndrome has been identified. For history of Gilbert syndrome, the limit is extended to 2-fold above the ULN.

5. Positive test results for human immunodeficiency virus (HIV-1 or HIV-2) antibody/antigen,
hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the Screening
visit. Healthy volunteers who have no evidence of cirrhosis and have completed a curative
intent regimen for HCV, with a negative HCV polymerase chain reaction (PCR) test, will not
be excluded.

6. Estimated creatinine clearance (CrCl) < 60 mL/min using the Cockcroft-Gault formula,
estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 using Chronic Kidney
Disease Epidemiology Collaboration (CKD-EPI) equation, or has a serum creatinine more than 1.5-fold above the ULN during Screening or at check-in day (Day -1).

7. History of substance abuse or alcohol abuse (defined as more than 14 standard drinks per week or regularly consuming more than 4 standard drinks on any one day; where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc./Vol], 100 mL wine [12% Alc./Vol], 30 mL spirit [40% Alc./Vol]) within 12 weeks prior to the Screening visit.

8. Positive drugs of abuse or alcohol breath test results at the Screening visit or at check-in (Day -1).

9. Use of any prescription medication within 2 weeks or 5 half-lives of the medication (whichever is longer) prior to study drug administration, except use of contraceptive or where in the opinion of the Investigator, particular use would not interfere with the volunteer’s ability to participate in the trial.

10. Demonstrated clinically significant (CS) (required intervention, e.g., emergency room visit, epinephrine
administration) allergic reactions (e.g., food, drug, or atopic reactions, asthmatic episodes)
which, in the opinion of the Investigator, would interfere with the volunteer’s ability to
participate in the trial.

11. Known hypersensitivity to any of the study drug ingredients, or other therapeutic proteins.

12. Administration of any live, attenuated vaccines within 30 days and all other vaccinations within 14 days prior to study drug administration.

13. For women of childbearing potential (WOCBP), a positive serum pregnancy test at the
Screening visit or a positive urine pregnancy test (with confirmatory serum pregnancy test) at check-in (Day -1).

14. Females who are breastfeeding or planning to breast feed at any time during the study.

15. Donation of blood or plasma within 30 days prior to first study drug administration, or loss of whole blood of more than 500 mL within 30 days prior to first study drug administration, or receipt of a blood transfusion within 6 months prior to first study drug administration.

16. Use of an investigational agent or device within 60 days or 5 half-lives (whichever is longer) prior to first study drug administration or current participation in an investigational study.

17. Any other condition, including mental illness or prior therapy that in the opinion of the
Investigator would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be assigned to receive the SC injection in the anatomical site that is currently being assessed at the clinical site that they are screened at. The participant will be randomly assigned to receive a single SC dose of 300 mg claseprubart using either the AI, APFS, or V/S method. This randomization is open-label and will take place using a randomization list or envelopes generated by a biostatistician and used by site staff. The participant will always receive the next available randomization number, unless they are a replacement participant.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
The sample size for this study was determined using a model-informed optimal design approach. This strategy was used to best estimate sample size consistent with the goal of study of characterizing the PK and evaluating potential differences in exposure of claseprubart between delivery devices and administered in various anatomic locations, rather than conduct a formal bioequivalence study.
The optimal design analysis evaluated the impact of sample size, sampling schedule, and study duration on the precision of key PK parameters, including clearance (CL), absorption rate constant (KA), and central volume of distribution (Vc). Simulations based on the current PopPK model that includes healthy volunteer data, the population to be included in this study, demonstrated that approximately 12 participants per cohort provides acceptable precision for the parameters needed to characterize the Cmax and AUC of claseprubart, with only minimal improvements observed with larger sample sizes or longer study duration.
The selected design provides sufficient precision for parameter estimation and is expected to be sensitive enough to identify clinically meaningful differences in exposure between delivery methods and anatomical locations. Therefore, sample size selection was based on achieving adequate precision and informative PK data while avoiding unnecessary participant burden.
Any participant who prematurely discontinues the study may be replaced by a new participant who would receive the same randomized device as the discontinued participant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/11/2026
Actual
Date of last participant enrolment
Anticipated
24/02/2027
Actual
Date of last data collection
Anticipated
7/04/2027
Actual
Sample size
Target
108
Accrual to date
Final
Recruitment outside Australia
Country [1] 28463 0
New Zealand
State/province [1] 28463 0

Funding & Sponsors
Funding source category [1] 322809 0
Commercial sector/Industry
Name [1] 322809 0
Dianthus Therapeutics Inc.
Country [1] 322809 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Dianthus Therapeutics Inc
Address
Country
United States of America
Secondary sponsor category [1] 325739 0
Commercial sector/Industry
Name [1] 325739 0
Bubble Clinical Research Services Ltd
Address [1] 325739 0
Country [1] 325739 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321249 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 321249 0
Ethics committee country [1] 321249 0
New Zealand
Date submitted for ethics approval [1] 321249 0
08/09/2026
Approval date [1] 321249 0
08/10/2026
Ethics approval number [1] 321249 0
2026 FULL 26744

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 153142 0
Dr Hannah Woo
Address 153142 0
NZCR, 3 Ferncroft Street, Grafton, Auckland 1010
Country 153142 0
New Zealand
Phone 153142 0
+6493733474
Fax 153142 0
Email 153142 0
[email protected]
Contact person for public queries
Name 153143 0
Rivka Gluck
Address 153143 0
Dianthus Therapeutics Inc, 7 Times Square, 43rd Floor, New York NY 10036
Country 153143 0
United States of America
Phone 153143 0
+1 929 999 4055
Fax 153143 0
Email 153143 0
[email protected]
Contact person for scientific queries
Name 153144 0
Rivka Gluck
Address 153144 0
Dianthus Therapeutics Inc, 7 Times Square, 43rd Floor, New York NY 10036
Country 153144 0
United States of America
Phone 153144 0
+1 929 999 4055
Fax 153144 0
Email 153144 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Privacy and intellectual property considerations



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.